Health product recall

Allura Xper and Azurion Systems

Last updated

Summary

Product
Allura Xper and Azurion Systems
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Allura Xper FD10 (Product Of AlluraClarity Family)

Not applicable.

722026

Allura Xper FD10/10 (Product Of AlluraClarity Family)

Not applicable.

722027

Azurion 7 M20

Not applicable.

722 224

Azurion 7 M20

Not applicable.

722 079

Azurion 7 M20

Not applicable.

722234

Allura Xper FD20/15

Not applicable.

722058

Allura Xper FD10

Not applicable.

001443

Allura Xper FD20/10 (Product Of AlluraClarity Family)

Not applicable.

722029

Azurion 7 M12

Not applicable.

722233

Azurion 7 M12

Not applicable.

722 223

Azurion 7 M12

Not applicable.

722 078

Azurion 3 M12

Not applicable.

722 063

Azurion 3 M12

Not applicable.

722 221

Azurion 3 M12

Not applicable.

722229

Azurion 5 M12

Not applicable.

722 227

Azurion 5 M12

Not applicable.

722231

Azurion 5 M20

Not applicable.

722 228

Azurion 5 M20

Not applicable.

722232

Allura Xper FD20 (Product Of AlluraClarity Family)

Not applicable.

722028

Allura Xper FD20/20 (Product Of AlluraClarity Family)

Not applicable.

722038

Azurion 7 B20

Not applicable.

722 226

Azurion 7 B20

Not applicable.

722236

Azurion 7 B20

Not applicable.

722 068

Azurion 3 M15

Not applicable.

722230

Azurion 3 M15

Not applicable.

722 064

Azurion 3 M15

Not applicable.

722 222

Azurion 7 B12

Not applicable.

722 067

Azurion 7 B12

Not applicable.

722235

Azurion 7 B12

Not applicable.

722 225

Allura Xper FD20 Or Table (Product Of AlluraClarity Family)

Not applicable.

722035

Issue

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch due to:

  • cable or connector damage (internal and/or external)
  • internal microswitch failure (each foot switch pedal activates two independent microswitches that - when both activated - release X-ray)
  • foot switch connector issues resulting from missing or incorrectly applied strain relief

No or intermittent X-ray could potentially result in a delay or abort of procedure.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Philips Medical Systems Nederland B.V.
Veenpluis 6, Best, Netherlands, 5684 PC
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81765

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